Events

Recall of Magnetom Espree

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Siemens Medical Solutions USA, Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    33308
  • Event Risk Class
    Class 2
  • Event Number
    Z-1529-05
  • Event Initiated Date
    2005-08-12
  • Event Date Posted
    2005-09-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-07-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=41674
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel data.
  • Extra notes in the data
    unknown device name - Product Code LNN
  • Reason
    There is a misalignment of the patient table that may occur between the patient table and the opening to the magnet bore.
  • Action
    The recalling firm issued via certified mail a Customer Safety Advisory to the affected customers per Update Instructions MR031/05/S. the letter informs customers of the potential issue and provides instructions to avoid its occurrence.

Device

Magnetom Espree
  • Model / Serial
    Serial numbers 30001 to 30075
  • Product Classification
    Radiology Devices
  • Distribution
    The products were shipped to medical facilities and MRI facilities nationwide.
  • Product Description
    Magnetom Espree. Magnetic Resonance Imaging System. model number 10018165
  • Manufacturer
    Siemens Medical Solutions USA, Inc

Manufacturer

Siemens Medical Solutions USA, Inc
  • Manufacturer Address
    Siemens Medical Solutions USA, Inc, 51 Valley Stream Pkwy, Malvern PA 19355-1406
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    USFDA